Deepak Lahane

Results-driven pharmaceutical professional with 17 years of expertise in Quality Control, specializing in method validation, analytical data review, and regulatory compliance. Proven success in managing Out of Specification (OOS), Out of Trend (OOT), and change control activities, utilizing advanced tools such as Quantum ERP, SAP, and Chameleon to enhance operational efficiency. Strong commitment to developing team proficiency in Standard Operating Procedures (SOPs) ensures strict adherence to cGMP, GxP, and 21 CFR Part 211 standards.

Strategic thinker focused on driving quality excellence and regulatory compliance within the pharmaceutical industry.

Manager in QC department - SRS Formulations Pvt. Ltd. - Wada, Palghar, Maharashtra

(2024-06)

• Managed overall quality control and micro department functions for compliance with GLP.
• Managed the release of raw materials, packing materials, and finished product samples according to the SOP.
• Executed all GLP and non-routine activities related to quality control and the microbiology department.
• Oversaw procurement, AMC, and preventive maintenance for QC instruments.
• Conducted investigations of OOS, OOT, OOC, lab incidents, and change control on a routine basis.
• Proposed CAPA based on investigations and monitored the effectiveness of implemented CAPA.
• Reviewed and approved method validation, cleaning validation, hold time study, process validation, and stability study protocols and reports.
• Prepared, reviewed, and approved specifications and standard operating procedures.
• Led QC departments during internal and external audits, ensuring compliance with observations.
• Installed and qualified new instruments, validated excel sheets, and performed CSV.
• Conducted audits of vendors to ensure compliance with quality standards. for raw materials & outside testing labs audits.

Assistant Manager in QC department - Stantech Pharma (Sydler Group) Pvt. Ltd. - Pune, MH

(2023-01 - 2024-05)

• Executed the release of raw materials, packing materials, and finished product samples in compliance with the SOP.
• Conducted GLP and non-routine activities for quality control and the microbiology department.
• Managed the procurement and maintenance of QC consumables and instruments.
• Developed and evaluated Quality Management System documentation.
• Evaluated analytical documents and instrument audit trails.
• Conducted preparation, review, and approval of specifications and standard operating procedures.
• Heading the QC departments for Internal & External audits
• Faced the FDA (MH), Vendor audits and also provided the compliance of observations.
• Developed reports for internal and external audit compliance.

Assistant Manager in QC - Felix Generics Pvt. Ltd. - Pithampur, MP

(2021-04 - 2022-08)

• Responsible for review and approval of Standard Operating Procedure.
• Managed daily analysis allocation to optimize resource utilization.
• Prepared and reviewed Quality Management System documentation, including OOS, OOT, OOC, lab incidents, and change control on a routine basis.
• Reviewed analytical documents and instrument audit trails.
• Reviewed and approved Standard Operating Procedures.
• Trended incidents of OOS, OOT, OOC, and deviations, and trained QC personnel based on trending outcomes.
• Monitored implemented CAPA and proposed actions based on investigation results.
• Allocation of daily analysis activity.
• Contributed to project implementation in QC focused on reducing laboratory incidents through 5S practices.
• Responsible for Handling of Method Validation Method Transfer & In Method Validation Method Transfer & In process team

Senior Executive - Lupin Pharmaceuticals Ltd. - Aurangabad, Maharashtra

(2014-07 - 2021-03)

• Handled the in-process and technology transfer section in the quality control department.
• Allocated in-process and technology transfer samples.
• Reviewed quality control data.
• Responsible for troubleshooting related to instrument, methodology in quality control department of routine as well as method transfer analysis.
• Operated analytical instruments including HPLC and GC like HPLC, GC, Malvern, UV, Auto titrator etc.
• Analyzed finished product, in-process, intermediate, and raw material samples.
• Responsible for calibrations of analytical instruments like HPLC, GC, UV, Balance etc.

Research Associate - Lupin Research Park - Pune, Maharashtra

(2011-05 - 2014-06)

• Conducted analytical method validation for drug products.
• Performed analysis on in-process samples, intermediate samples, and raw materials.
• Operated various analytical instruments to conduct tests. like HPLC, UV, GC, IR, Malvern, Potentiometer etc.

Officer QC - AMRI India Pvt. Ltd. - Aurangabad, Maharashtra

(2010-12 - 2011-05)

• Conducted analysis of finished product, in-process, intermediate, and raw material samples.
• Operated various analytical instruments in laboratory settings like HPLC, UV, GC, IR, Potentiometer etc.
• Led operational compliance initiatives to enhance safety protocols and regulatory adherence.
• Developed training programs to improve team performance and knowledge retention.
• Streamlined workflow processes, resulting in increased efficiency across departments.

Officer QC - Alembic Pharmaceuticals Pvt. Ltd. - Vadodara, Gujarat

(2009-03 - 2010-11)

• Analyzed finished product, in-process, intermediate, and raw material samples.
• Operated analytical instruments in laboratory for sample testing like HPLC, UV, GC, IR, Potentiometer etc.
• Oversaw compliance with regulatory requirements, ensuring adherence to safety standards and operational protocols.
• Trained and mentored junior staff, fostering a culture of continuous learning and development.
• Developed and implemented process improvements, enhancing efficiency in daily operations.

M.Sc. - Analytical Chemistry - Marathwada University, Aurangabad, Maharashtra (2008)

B.Sc. - Chemistry - Marathwada University, Aurangabad, Maharashtra (2006)